Kornimate/medical-research-clean huggingface dataset:
study of letrozole with or without palbociclib (pd-0332991) for the first-line treatment of hormone-receptor positive advanced breast cancer

Conditions: Breast Cancer

Summary: the study is aimed to confirm that letrozole + pd 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer


Eligibility criteria:
inclusion criteria: * inoperable estrogen receptor positive and her2 negative breast cancer. * postmenopausal status. * tumor tissue (archived acceptable) available for biomarker studies. for phase 2 part 2 - ccnd1 amplification and/or loss of p16 as determined by the central laboratory. * acceptable bone marrow, liver and kidney function. exclusion criteria: * prior or concomitant treatment for advanced breast cancer. * other major cancer in the past 3 years. * important cardiovascular events in the past 6 months.

Keywords: hormone-receptor positive advanced breast cancer
integration of tai chi and repetitive transcranial magnetic stimulation for sleep disturbance in older adults

Conditions: Sleep Disturbance; Interaction

Summary: this is a novel and the first study to investigate the impacts of the integrated treatment of tai chi (tc) and repetitive transcranial magnetic stimulation (rtms) on sleep disturbances and the potential mechanisms of arousal system. to validate the combination of tc and rtms as a promising approach for managing sleep disturbance in older adults, the investigators will conduct a four-arm, parallel-group, randomized controlled trial comprising a 4-week treatment phase and a 3-month follow up period. a total of 152 eligible participants will be recruited and randomly assign to the tc plus active rtms (38 participants), tc plus sham rtms (38 participants), tc-alone (38 participants), and low-intensity pe (38 participants) control group within two weeks after the baseline assessment. tc plus active rtms, tc plus sham rtms, and tc-alone will be compared with a low-intensity pe control group on insomnia severity, various sleep parameters assessed by self-report sleep diary and actigraph, emotional states, and physical and mental health related quality of life. the investigators have formulated two hypotheses in this study. first, the three intervention groups, relative to participants undergoing pe, will confer greater improvement in all measured outcomes at post-intervention (t1) and three-month follow-up (t2); and second, in the double-blinded groups, the tc plus active rtms will show greater improvement in all measured outcomes than tc plus sham rtms at t1 and t2.


Eligibility criteria:
inclusion criteria: 1. age of at least 60 years 2. active sleep disturbance as indicated by the pittsburgh sleep quality index (psqi) score exceeding 5 and the insomnia severity index (isi) score greater than 7 at screening 3. no prior experience of mind-body exercises (i.e., tc, qigong, or yoga, etc.) and regular moderate-intensity exercise (i.e., above three times per week and 30 minutes per session) in the past 6 months 4. provide written informed consent exclusion criteria: 1. cognitive impairment as determined by the montreal cognitive assessment scored less than 22 2. major confounding conditions known to induce sleep perturbations, such as psychiatric disorders or chronic pain disorder 3. history of head injury or epilepsy, intracranial implant, cardiac pacemaker, or any other contraindication to rtms 4. obvious physical disability that precluded participant in the interventions
investigation of occupational balance in individuals with and without bruxism

Conditions: Bruxism; Occupational Problems

Summary: considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.

occupation refers to daily life activities and task groups that are named, organized, given value and meaning by individuals and a culture. occupation is everything people do to keep themselves busy, including taking care of themselves, enjoying life, and contributing to the social and economic fabric of their communities. bruxism is a parafunctional habit among temporomandibular disorders that occurs as a result of clenching and grinding teeth and overloading the stomatognathic structures. at the same time, bruxism is the chewing movement of the mandible, characterized by involuntary, rhythmic and non-functional teeth clenching and grinding, usually seen during sleep, and manifested by severe head and neck pain, limitation in jaw movements, pain and spasm in the chewing muscles. although its etiology cannot be fully explained, it is thought that factors such as stress, occlusal disorders, allergies and sleep quality may be the source. the deterioration or decrease in occupational balance may also be associated with people's quality of life. occupational imbalance is reported to affect both physical and psychological state, creating significant stress on the body and mind, causing mental health problems and burnout. considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.

Eligibility criteria:
inclusion criteria: * to be volunteer exclusion criteria: * psychological disorders, * neurological disorders, * orthopedic disorders, * cognitive impairment.

Keywords: bruxism occupational balance stress
prediction and close monitoring of postoperative recurrence by intestinal ultrasound after ileocecal resection in crohn's disease patients

Conditions: Crohn Disease

Summary: crohn's disease (cd) is an inflammatory bowel disease causing chronic transmural inflammation followed by intestinal complications including strictures and penetrating lesions such as fistulas and abscesses. 30-50% of the cd patients will require surgery during the course of their disease. unfortunately, resection is not curative and endoscopically recurrent lesions (i.e. endoscopic recurrence) are observed in 65-90% of patients within 12 months, and in 80-100% within 3 years after the operation. eventually 15-20% of patients will require new surgery within 5 years. close monitoring for postoperative recurrence is therefore needed to perform early intervention and prevent clinical recurrence and need for re-surgery. endoscopy is the gold standard to assess postoperative disease recurrence however it's limited by its invasiveness. cross sectional imaging is known for accurate detection of postoperative recurrence. intestinal ultrasound (ius) of the colon and (neo)terminal ileum correlates well with ct, mre and colonoscopy findings in the postoperative setting. ius is non-invasive, cheap, readily available and may show early, signs of disease recurrence. therefore it could be a useful tool to predict endoscopic recurrence at 6 months.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of crohn's disease * undergoing icr (or re-resection) * ≥16 years of age exclusion criteria: * \<16 years of age * inability to give informed consent * ongoing gastroenteritis * deviating stoma * (sub)total colectomy * obesity (bmi \>35 kg/m²) * insufficient visualization of the anastomosis and the neo-terminal ileum at baseline ius
adding atomoxetine to standard medication treatment in patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: this study will compare atomoxetine to placebo when taken with current standard alzheimer's disease medications. the treatment will take approximately 6 months and it is hypothesized atomoxetine will significantly improve cognitive performance as compared to placebo.


Eligibility criteria:
inclusion criteria: * patient presents with alzheimer's disease based on clinical history. * patient must have a mini mental status score between 10 and 26. * patient must have a reliable caregiver in frequent or daily contact with the patient. * patient must be currently treated with and on a stable dose of a standard alzheimer's drug treatment for at least 3 months. exclusion criteria: * patients who are receiving pharmacologic treatments (other than a cholinesterase inhibitor or memantine) for alzheimer's disease. * patients who have a history in the past 5 years or any current evidence of major psychiatric illness. * patients who have narrow angle glaucoma. * patients who are experiencing clinically significant urinary hesitancy or retention as assessed by a physician.
hearing program in primary care

Conditions: Deafness

Summary: during a primary care visit, investigators will screen and identify participants with hearing loss and then randomize to a) counseling on accessible assistive listening devices or b) referral to traditional audiology care pathway alone.


Eligibility criteria:
inclusion criteria: * speaks english or spanish; * capacity to consent to research exclusion criteria: • has or uses hearing aids or cochlear implants
glenoid bone grafting for rtsa: clinical & radiographic outcomes

Conditions: Osteo Arthritis Shoulders

Summary: this study will look at patient radiographic and functional outcomes who have or will undergo a reverse, extended peg, shoulder arthroplasty (replacement) that requires the use of glenoid bone grafting.

glenoid bone loss is a known issue with reverse shoulder implants and can lead to issues with implant fixation and stability over time. to address this issue an extended peg glenoid baseplate is used and area around plate is augmented with bone (auto or allo)graft material to encourage bony callous growth around the implant. this study is to look at this area of concern and determine if glenoid bone loss is occurring in the patients where these measures have been taken to deter its development.

Eligibility criteria:
inclusion criteria: 1. adult patients who have undergone a reverse shoulder arthroplasty with the an extended peg baseplate and structural bone graft (autograft humeral head or allograft femoral head). 2. adult patients who are indicated for a long-pegged baseplate and glenoid bone grafting (autograft humeral head or allograft femoral head) as part of their reverse shoulder arthroplasty in our clinic, 3. bone graft is truly structural involving at least 50% of the glenoid baseplate 4. may be a primary or a revision surgery exclusion criteria: 1. patients with missing baseline (preop) data, 2. patients who are unwilling to participate in a final follow-up evaluation.

Keywords: reverse total shoulder arthroplasty glenoid bone loss
postoperative complications after liver transplantation

Conditions: Liver Transplantation; Postoperative Renal Complication; Postoperative Pulmonary Complication; Postoperative Cardiovascular Complication; Blood Components Transfusion

Summary: incidence and risk factors for renal, cardiovascular and pulmonary complications after liver transplantation are not well defined. blood products requirement is an important aspect of orthotropic liver transplantation (oltx) management and has a great impact on patient's outcome. transfusions of blood products increase perioperative complications and reduce graft and patients survival. the primary endpoint of the study is to evaluate the incidence of renal complication during icu stay after liver transplantation using rifle criteria; secondary endpoint is to evaluate the incidence of cardiovascular and pulmonary complications. in addition patients' survival and the relationship between blood components use with the development of post-operative complications are evaluated.

it is conducted a prospective observational cohort study in all italian liver transplant centers. adult (\> 18 years old) recipients of deceased liver graft between january 2011 and december 2013 were eligible for inclusion. exclusion criteria were the use of living organ donation, retransplantation, pediatric transplantations, combined transplantation and fulminant hepatic failure. investigators collected data using a prospectively maintained computer database managed by the italian ministry of health "centro nazionale trapianti". anesthetic and perioperative management followed the routine local institution protocols.

Eligibility criteria:
inclusion criteria: * 18 years old or more exclusion criteria: * age less than 18 years; * liver transplantation living related donor; * retransplantation; * combined transplantation; * fulminant hepatic failure;
stroke rehabilitation outcome during covid-19 lockdown

Conditions: Stroke; Rehabilitation; COVID-19; Cohort Studies

Summary: covid-19 has a big impact on individuals and society as a whole. especially persons with (multiple) comorbidities such as stroke are affected. the impact of covid-19 on stroke rehabilitation delivery and stroke patients' functioning is unclear.

with 16'000 patients hospitalized and with new permanent disability in approximately 7'000 individuals every year in switzerland, stroke has a major impact on quality of life and is an enormous socioeconomic burden. virtually all patients receive inpatient rehabilitation in the sub-acute phase poststroke. however, also in the later phases poststroke, patients receive rehabilitation interventions in outpatient rehabilitation clinics and private practices, with goal to improve or maintain their functional capacity. currently, switzerland finds itself in an extraordinary situation. the federal council has issued a series of measures aimed at the population, organizations and institutions, and the cantons. the aim is to curb the spread of the coronavirus and assure the provision of healthcare. the people are invoked to stay at home and only leave the home if absolutely necessary. if they are over the age of 65 or have an underlying medical condition, the federal council strongly recommend that you stay at home under any circumstances unless you have to go to the doctor. with the recommendation of the swiss federal council almost all stroke patients belong to the group who should stay home. furthermore, all outpatient rehabilitation clinics have reduced the interventions to a minimum. it is unknown how a sudden stop of rehabilitation influences the stroke patients' functional capacities and their perceived quality of life.

Eligibility criteria:
inclusion criteria: * ischemic or haemorrhagic stroke, confirmed by mri-dwi and/or ct * participating in a stroke research project before the lockdown (estrel - basec nr. 2018-02021/ re-use - basec-nr. 2017-01070) * age 18 years or older * verbal and written informed consent of the patient after participants' information exclusion criteria: * severe communication or cognitive deficits, that cause inability to follow the procedures
prenatal breast pump education of mothers and their support person

Conditions: Preterm Birth; Breast Feeding

Summary: the study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to initiation of breast pumping, decrease time to lactogenesis stage ii and increase breast milk production.

compelling evidence exists that breast milk helps protect premature infants from prematurity-specific morbidities, including feeding intolerance, late onset sepsis, and necrotizing enterocolitis. unfortunately, mothers of vlbw infants often exhibit delayed lactogenesis stage ii (when the milk "comes in") and inadequate breast milk production. earlier initiation of breast milk expression following delivery is associated with increased lactation success. however, lack of nursing time and lack of hospital personal are significant barriers to the early initiation of milk expression in this population. the proposed study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test 1 primary aim and 1 secondary aim. aim 1: will evaluate the feasibility of antenatal bm pumping education for sps of mothers of preterm infants. issues related to recruitment, randomization acceptance of the intervention, and refinement of the education materials and process will be scrutinized. aim 2 will estimate variability of outcome measurements and effect sizes needed to calculate the sample size for a subsequent larger, adequately powered, randomized clinical trial. eligible women and their sp will be randomly assigned to one of two groups. group 1 will receive a prenatally delivered lactation educational program including video recordings, a demonstration of how the pump works and will have a breast pump available in their room. the volume of breast milk produced, timing of lactation stage ii, duration of lactation and stress during initial expression will be measured. in addition, breast milk sodium levels will be analyzed on day 1-7, day 14 and 21.

Eligibility criteria:
inclusion criteria: * english speaking * stated intent to breastfeed * anticipating the birth of a premature infant \< 35 weeks gestation. exclusion criteria: * known illicit maternal drug use * history of breast reduction or augmentation * positive hiv status * infant not expected to live over 2 weeks following delivery.

Keywords: preterm breast milk
narrative exposure therapy for adults with an intellectual disability

Conditions: Trauma, Psychological; Learning Disability; PTSD; Intellectual Disability, Mild

Summary: the goal of this naturalistic single case series design is to investigate if an adapted narrative exposure therapy protocol can be effective, is feasible, and acceptable for adults with a mile learning disability. participants will be complete three baseline sessions before taking part in narrative exposure therapy using a manual that has been adapted for people with a learning disability. trauma symptoms will be measured weekly using the impact of events scale adapted for intellectual disabilities. the person's carer will also complete an informant scale related to these symptoms (lants-iv). the client will also complete the core-ld at pre, and post therapy. six weeks after the end of the intervention, the client and their carer will be invited to a feedback session to talk about how they found the intervention.


Eligibility criteria:
inclusion criteria: * age 18 and over * meet the criteria for having a mild id as assessed by a clinical psychologist within the team * english speaking * have capacity to consent * the participant must be experiencing trauma related stress as assessed by themselves, the clinical psychologist and the research team * be able to travel to one of the therapy sites * carer participant must have ability to reflect and comment on the trauma related stress experienced by the client participant * carer must also be 18 years old or older and be english speaking. * carer must have known participant for 1 year or more. exclusion criteria: * they are substance dependent * they are currently receiving another trauma-focused intervention * currently an inpatient * carers excluded if they lack capacity to consent to take part in research
clinical application of 68ga-fapi pet imaging in detection of ovarian cancer recurrence

Conditions: 68Ga-FAPI; Ovarian Cancer; Epithelial Ovarian Cancer; Positron Emission Tomography

Summary: this is a prospective study to investigate the potential efficacy of 68ga-fapi pet/ct for recurrence detection of epithelial ovarian cancer in comparison with 18f-fdg pet/ct.

gallium 68-labeled fibroblast-activation protein inhibitor (68ga-fapi) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of fapi findings is not well established.

Eligibility criteria:
inclusion criteria: * adult patients (age\>18 and\<80 years) * patients with clinically suspected recurrent ovarian cancer * patients who underwent paired 18f-fdg and 68ga-fapi pet/ct for the most proper treatment strategy within 1 week * patients who did not receive any other treatment 4 weeks before pet imaging exclusion criteria: * pregnant patients * patients with poor performance status * patients unwilling to provide written informed consent

Keywords: 68ga-fapi pet ovarian cancer recurrence detection
zinc for the treatment of herpes simplex labialis (hsl)

Conditions: Herpes Simplex Labialis

Summary: evaluate the effectiveness of a topical preparation of zinc to treat cold sores.

zinc salts irreversibly inhibit herpes virus replication in vitro and are effective in treating herpes infections in vivo and have been shown in a clinical trial to be a effective topical treatment for hsl. zinc salt solutions applied to herpetic lesions decrease viral load and markedly improve healing rates, relieving the symptoms of herpes as healing occurs. zinc swabs contain 33 mmol/l of ionic zinc in an emulsification of benzalkonium chloride, glycerin, hydroxyethylcellulose, sodium chloride, and sodium hydroxide (ph 7.2). zinc gluconate is monographed in the homeopathic pharmacopoeia of the united states (hpus) and one of otc indications for zinc and its salts is for the treatment of cold sores.

Eligibility criteria:
inclusion criteria: * subjects with a history of hsl with at least 2 episodes/year for the past two years that have proceeded beyond the prodromal (initial) stage * male or female subjects between 18 and 65 years of age * symptoms or signs of hsl for less than one day (max. 36 hours from onset of symptoms to first visit) * confirmation of hsl by a clinician at the study site * willing to comply with study instructions and sign an informed consent exclusion criteria: * hsl symptoms or signs for more than one day * cold sore outbreak within the past 2 weeks * previous participation in this clinical trial * topical or oral antiviral drug use in the past 1 week * immune deficiency (hiv positive), chronic steroid therapy, present anti-neoplastic or radiation therapy, hodgkin's disease, splenectomy, leukemia, myeloma, lymphoma, or another condition/drug per judgment of attending health care professional) or currently taking immune suppressive drugs. previous organ or bone marrow transplant. * pregnancy or lactation * unable to travel to the clinic area for the required visits * apparent inability to understand or follow the instructions associated with the clinical study * history of adverse events to the study material or facial cosmetics

Keywords: cold sores zinc hsl herpes simple labialis
delivering hope (helping women optimize prenatal equity)

Conditions: Gestational Weight Gain; Diet, Healthy; Gestational Hypertension; Gestational Diabetes; Pregnancy Complications

Summary: the overarching research question is: "does the provision of healthy food (delivering hope) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (esoc)?" to answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. women will be randomized to either the delivering hope arm or the esoc arm, with approximately 720 participants per arm. participants randomized to the esoc arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, wic and snap enrollment assistance, referrals to safety net food organizations.those randomized to the delivering hope arm will be provided the same nutritional and gestational weight gain counseling, wic and snap assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.


Eligibility criteria:
inclusion criteria: * aged 16-44 years * ≤18 weeks pregnant * speak english, spanish, or marshallese